BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2221214 · Received August 24, 2011

    Report

    Report Number
    2939301-2011-07963
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 6, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. THE 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT STATED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT APPROXIMATELY 9:30PM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "222 AND 167MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. THE PATIENT INFORMED THE CCA THAT HE MANAGES HIS DIABETES WITH AN UNKNOWN TYPE OF INSULIN, 10 UNITS, AND GLIPIZIDE PILLS, 10 MG. THE PATIENT DENIED MAKING ANY CHANGES TO HIS NORMAL DIABETES MANAGEMENT ROUTINE DUE TO THE ALLEGED ISSUE. APPROXIMATELY 1 HOUR AND 45 MINUTES LATER, THE PATIENT CLAIMED HE WAS FEELING "LIGHT HEADED, HAD COLD SWEATS AND A SLIGHT LOSS OF BALANCE." THE PATIENT STATED HE CONSUMED MORE FOOD AND DRINK AT APPROXIMATELY 11:40 PM (20 MINUTES AFTER THE SYMPTOMS BEGAN). AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE METER WAS IN THE CORRECT UNIT OF MEASURE. THE SAMPLE WAS DRAWN FROM THE SAME APPROVED SOURCE. A CONTROL SOLUTION TEST WAS PERFORMED AND THE RESULT FELL WITHIN SPECIFICATIONS PRINTED ON THE VIAL OF SUBJECT STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3154344

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R